MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SHUNT SENSOR SYS500; BLOOD GAS MONITOR

Model Number CDI510H

Device Problem Calibration Error (1078)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

The returned sample was visually inspected upon receipt, during which no anomalies were noted.A review of the device history revealed no production related anomalies.Using the cdi 500 and cdi 540, gas calibration on the returned sample was attempted.The attempt resulted in the completion of calibration with an error appearing for slope error in pco2, po2, and ph.Although the failure mode seen by the customer was able to be recreated during the investigation, a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, while the shunt sensor was being calibrated during set up, a sensor error was displayed and the unit was unable to be calibrated.Calibration was attempted again with the same result.The product was changed out and the procedure was completed successfully.It is unknown if there was any delay in beginning or continuing the procedure.

• Brand Name: SHUNT SENSOR SYS500
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5460630
• MDR Text Key: 39029502
• Report Number: 1124841-2016-00073
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: TK17H
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1